FDA's New One-Day Inspection Pilot: More Efficient Oversight or More Questions Than Answers?

By Brynn Stanley

The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new inspection model intended to expand FDA oversight through shorter, more targeted inspections of FDA-regulated facilities. According to FDA, the initiative is designed to improve inspection efficiency, increase surveillance coverage, and help the agency focus resources where they are most needed. As of late April 2026, FDA reported completing approximately 46 one-day assessments, most of which resulted in No Action Indicated (NAI) outcomes.

While FDA has characterized the pilot as a supplemental oversight tool rather than a replacement for traditional inspections, the announcement raises several important questions regarding transparency, resource allocation, and the agency's increasing use of artificial intelligence in regulatory decision-making.

What Are One-Day Inspectional Assessments?

The pilot, which launched in April 2026, utilizes focused screening assessments that FDA intends to complete in approximately one day. Facilities are selected using risk-based criteria, including product type, inspection history, and operational characteristics. FDA has indicated that the pilot applies primarily to lower-risk facilities and does not replace traditional inspections of higher-risk or more complex operations.

FDA has also stated that information gathered during these assessments may be used to improve future risk models and oversight activities, including identifying recurring compliance themes and facility-specific risk indicators.

Key Questions the Industry Should Be Asking

Where Is the Inspection Program Guidance?

Historically, FDA inspection programs have been governed by Compliance Program Guidance Manuals (CPGMs), inspection guides, and publicly available procedures that provide transparency regarding inspection scope and expectations.

To date, FDA has not released a dedicated compliance program or detailed inspection framework governing One-Day Inspectional Assessments. As a result, industry currently has limited visibility into:

• The specific inspectional objectives of the pilot;
• The records and systems likely to be reviewed;
• The criteria investigators will use to determine whether an assessment should be expanded; and
• How findings will be evaluated and documented.

For many manufacturers, the absence of publicly available inspection guidance represents a notable departure from FDA's traditional inspection model and may create uncertainty regarding how to prepare for these assessments.

How Is FDA Using Artificial Intelligence?

FDA officials have indicated that artificial intelligence and advanced analytics are being used to help identify facilities for inspection. FDA announced the launch of Elsa 4.0, the Agency’s internal AI tool, on the same day as the One-Day Inspection Pilot. That timing may signal an increasing role for AI tools in inspection planning and risk prioritization.

That development raises important questions:

• What data is being used to identify inspection targets?
• How are AI-generated recommendations validated before being relied upon?
• What safeguards exist to prevent inaccurate or biased outputs?
• Will inspection findings be used to train future FDA risk models?

As FDA expands its use of AI across regulatory functions, manufacturers will likely seek greater transparency regarding validation, governance, and oversight of these systems.

Is This the Best Use of FDA Resources?

FDA has described the program as a way to expand oversight coverage without increasing regulatory burden. However, the actual resource commitment extends beyond a single day. Even a "one-day" inspection requires:

• Pre-inspection planning;
• Travel and logistics;
• On-site assessment activities;
• Establishment Inspection Report preparation;
• Supervisory review; and
• Potential follow-up actions.

Every investigator conducting a one-day assessment is necessarily unavailable to perform other FDA responsibilities, including inspections of higher-risk facilities, recall follow-up activities, compliance investigations, and support for premarket review programs.

Whether the pilot ultimately improves overall inspection efficiency remains an open question, and FDA will need to demonstrate its value through measurable outcomes.

Can Quality System Reviews Really Be Compressed?

The concept of compressing inspection activities is not new. When FDA introduced the Quality System Inspection Technique (QSIT), the agency similarly sought to standardize and streamline inspection activities.

One lesson from prior inspection modernization efforts is that shortening an inspection does not necessarily increase the amount of meaningful compliance information obtained. Quality systems are highly interconnected, and significant compliance concerns often emerge only after investigators have sufficient time to follow audit trails, review records, and explore systemic issues.

A shorter inspection may reduce disruption for compliant facilities. Whether it produces better regulatory outcomes remains to be seen.

What Should Manufacturers Expect?

Manufacturers should anticipate that FDA may increasingly use shorter, targeted assessments as an initial screening tool, particularly for facilities with lower-risk products and favorable compliance histories.

Companies should also expect:

• Less advance notice and less time to gather records;
• Highly focused requests targeting specific quality system elements;
• Greater reliance on data analytics and risk-based selection criteria;
• The possibility that a one-day assessment expands into a longer inspection if investigators identify concerns; and
• Increased emphasis on maintaining continuous inspection readiness rather than preparing for periodic multi-day inspections. 

Importantly, a one-day assessment is not necessarily a lighter inspection. The compressed timeline may actually require companies to produce records, answer questions, and demonstrate compliance much more quickly than during a traditional inspection.

How Can Manufacturers Prepare Now?

Organizations should consider taking several proactive steps:

1. Assume Inspection Readiness Is Now a Daily Requirement

Inspection readiness can no longer depend on having several days to assemble documents after investigators arrive.

2. Test Rapid Document Retrieval

Evaluate whether critical records can be produced within hours, including:

• Corrective and Preventive Action (CAPA) records;
• Complaint files;
• Internal audit reports;
• Training records;
• Supplier controls; and
• Design and validation documentation.

3. Review Quality System Data for Emerging Trends

FDA's risk-based selection process appears increasingly dependent on data analytics. Manufacturers should proactively evaluate complaint trends, CAPA effectiveness, supplier performance, and recurring quality issues before FDA does.

4. Prepare Personnel for Focused Interviews

Shorter inspections leave less time for clarification. Employees should be prepared to answer investigator questions clearly, consistently, and efficiently.

5. Monitor FDA Developments Closely

Many operational details regarding the pilot remain unknown. Additional FDA guidance, metrics, and implementation details may significantly influence how these assessments evolve through FY 2026.

Key Takeaway

FDA's One-Day Inspectional Assessment pilot reflects the agency's broader movement toward risk-based oversight, expanded use of data analytics, and increased operational efficiency. While the initiative may allow FDA to visit more facilities, important questions remain regarding transparency, AI governance, inspection effectiveness, and resource allocation.

Until FDA provides additional details, manufacturers should focus on maintaining continuous inspection readiness and assume that even a "one-day" inspection may carry the same regulatory consequences as a traditional multi-day review.

How Gardner Law Can Help

Gardner Law helps FDA-regulated companies prepare for inspections, respond to inspectional observations, and strengthen quality and compliance programs before regulators arrive. Our team combines former industry experience in quality, engineering, and regulatory affairs with legal counsel to help manufacturers assess inspection readiness, conduct mock inspections, evaluate quality system vulnerabilities, develop FDA response strategies, and navigate enforcement actions. As FDA continues to expand the use of risk-based oversight and emerging technologies, we help clients understand evolving regulatory expectations and implement practical, business-focused compliance solutions.